A PHASE IIIB, RANDOMIZED, TRIAL OF OPEN-LABEL EFAVIRENZ OR ATAZANAVIR WITH RI

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 具体目标： 主要研究： 三个主要目标是： 1. 比较病毒学失败方案之间的病毒学疗效，病毒学失败定义为至确认的血浆HIV-1 RNA水平在16周或之后和24周之前≥ 1000拷贝/mL或在24周或之后≥ 200拷贝/mL的时间。 2. 比较治疗方案之间的安全性，安全性定义为至首次出现3级或4级体征、症状或实验室检查异常的时间，至少比基线时高1级。 3. 比较治疗方案之间的耐受性，耐受性定义为初始治疗方案中一种或多种药物发生变化的时间。 代谢子研究： 主要目标是： 1. 评估开始含ABC/3 TC或FTC/TDF的ARV方案（B/D或A/C组）后治疗组内外周脂肪变化（肢体脂肪）的变化。 2. 通过腰椎和髋关节DEXA评估，比较含ABC/3 TC的ARV方案与含FTC/TDF的ARV方案对骨密度（BMD）的影响（B/D组vs A/C组）。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. SPECIFIC AIMS: Main Study: The three primary objectives are: 1. To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level =1000 copies/mL at or after 16 weeks and before 24 weeks or =200 copies/mL at or after week 24. 2. To compare the safety between regimens with safety defined as the time to first development of Grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline. 3. To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen. Metabolic Sub-Study: The primary objectives are: 1. To assess changes within treatment arms in peripheral fat changes (limb fat) after the initiation of an ARV regimen containing ABC/3TC or FTC/TDF (Arms B/D or A/C). 2. To compare the effects of initiation of an ARV regimen containing ABC/3TC with those of a regimen containing FTC/TDF on bone mineral density (BMD), as assessed by lumbar spine and hip DEXA (Arms B/D versus A/C).